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Results For "NSCLC"

115 News Found

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer
Drug Approval | November 19, 2024

Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years


Merck and Moderna initiate Phase 3 trial evaluating adjuvant V940 in combination with Keytruda
News | November 01, 2024

Merck and Moderna initiate Phase 3 trial evaluating adjuvant V940 in combination with Keytruda

The INTerpath-009 clinical trial demonstrates continued expansion of the INTerpath clinical program


AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression


Datopotamab deruxtecan showed median overall survival of 14.6 months in TROPION-Lung01 Phase III trial
Clinical Trials | September 10, 2024

Datopotamab deruxtecan showed median overall survival of 14.6 months in TROPION-Lung01 Phase III trial

TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population


Bayer starts Phase III trial in non-small cell lung cancer
Clinical Trials | August 30, 2024

Bayer starts Phase III trial in non-small cell lung cancer

First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations


Natco Pharma announces submission of TABRECTA to USFDA
Drug Approval | August 30, 2024

Natco Pharma announces submission of TABRECTA to USFDA

TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA


Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer
Drug Approval | June 26, 2024

Tagrisso with the addition of chemotherapy approved in Japan as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer

Approval based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care


USFDA approves next-gen TKI Augtyro for treatment of solid tumors
Drug Approval | June 17, 2024

USFDA approves next-gen TKI Augtyro for treatment of solid tumors

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors


AstraZeneca’s Tagrisso plus chemo recommended for approval in EU
Drug Approval | June 05, 2024

AstraZeneca’s Tagrisso plus chemo recommended for approval in EU

Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months